Should You Get Pills or Surgery for Atrial Fibrillation?

Many older Americans have the worrisome and potentially dangerous irregular heartbeat known as atrial fibrillation, or “a-fib,” and they’re typically offered medicines or a surgery called ablation to correct it.

Which works best?

Two new trials may have the answer. Researchers say ablation and medicines perform similarly in protecting a-fib patients from stroke, death and other complications.

However, ablation may beat out drug therapy over the long term, reducing recurrences of a-fib and related hospitalizations for years to come, researchers say.

Patients who got ablation — where a catheter is used to tweak the heart muscle cells responsible for the arrhythmia — also seemed to have less shortness of breath, less fatigue and all-around better quality of life five years later, compared to those who got drug therapy alone.

The quality-of-life trial, “because of its size and duration, provides extraordinary new data regarding the patient’s perspective,” said Dr. Yves Rosenberg.

He was program officer for the study, and is also chief of the Atherothrombosis and Coronary Artery Disease Branch at the U.S. National Heart, Lung, and Blood Institute (NHLBI), which helped fund both trials.

A cardiologist who reviewed the findings said the data should reassure patients.

“I think the takeaway from this study is that catheter ablation is effective and safe for treating atrial fibrillation,” said Dr. Laurence Epstein, who directs electrophysiology at Northwell Health in Manhasset, N.Y.

“If you have atrial fibrillation and are symptomatic, ablation is a reasonable first-line option, as opposed to taking drugs,” he said.

Treatment pros and cons

According to the NHLBI, a-fib affects at least 2.7 million Americans and can lead to stroke, heart failure, and even mental impairment. Symptoms include rapid heart palpitations (“flip-flops” or skips); fatigue; shortness of breath, and difficulty doing physical activity.

“Since current drug therapies often have limited effectiveness in controlling atrial fibrillation, it is very important to understand whether ablation, an invasive procedure, yields better outcomes,” Dr. David Goff, director in the division of cardiovascular sciences at the NHLBI, said in an institute news release.

As Epstein explained, during ablation, “long catheters — wires with electrodes on them — are placed into the heart via the large veins in the groin. Radio waves are delivered from the catheter to the heart muscle, which causes heat and the controlled destruction of the muscle cells responsible for causing atrial fibrillation.”

Sometimes ablation is performed using tiny balloons that freeze the heart muscle to create the same effect.

Of course, no treatment is foolproof. “Depending on the patient the procedure can be as effective as 80-90 percent,” Epstein said, “but in others, at best, 50 percent.”

Many other patients get drug therapy alone to control the aberrant heart rhythm. But Epstein said outcomes are often “disappointing because the drugs do not work that well and that they can cause ‘pro-arrhythmia.’

“Pro-arrhythmia is when a drug used to treat an abnormal heart rhythm can actually cause a worse, more dangerous heart rhythm,” he explained.

Long-term benefits

To settle the meds-versus-ablation debate, the NHLBI helped conduct these two trials, which included more than 2,200 patients treated at 126 sites in the United States, Canada, Asia and Europe.

Half the patients had ablation and half were put on drug therapy, but could have ablation if their a-fib symptoms could not be controlled with medication — something known as “intent to treat.”

In the end, about 27 percent of the patients who started on drug therapy did end up undergoing ablation.

The median follow-up of patients in the trial was about four years.

“While data from the trial did not show that ablation was superior to drug therapy in reducing rates of deaths and strokes, it showed reduced recurrence of atrial fibrillation, as well as reductions in hospitalizations,” Rosenberg said in the news release.

The researchers noted that the overall rate of deaths and strokes was lower than expected. Also, about 9 percent of the patients assigned to receive ablation did not, in the end, undergo the procedure.

So, “when we examined the data according to the treatment actually received, the ablation group had significantly lower rates of death as well as the combination of death, disabling stroke, serious bleeding, or cardiac arrest compared with patients who only received drug therapy,” said study principal investigator Dr. Douglas Packer. He’s a cardiologist and professor of medicine at Mayo Clinic in Rochester, Minn.

The research team found that 12 months after the start of treatment, both groups of patients had at least some improvement in their quality of life. However, those in the ablation group had a larger decline in symptoms such as fatigue and shortness of breath, and their boost in quality of life lasted through five years of follow-up.

At the start of the study, 86 percent of patients in the ablation group and 84 percent on drug therapy reported atrial fibrillation symptoms during the previous month. By the end of the study, only 25 percent of patients in the ablation arm and 35 percent of those on drugs only reported symptoms.

Patients with the most severe symptoms at the start of the study had much greater improvement after ablation than those who initially had mild symptoms, the researchers added.

Dr. Satjit Bhusri is a cardiologist at Lenox Hill Hospital in New York City. Reviewing the new data, he said that the trials give doctors and patients valuable guidance.

First of all, he said, if your a-fib isn’t so bad that it harms your quality of life, perhaps controlling it with medicines alone might work. However, when quality of life is affected, a move to ablation therapy may be warranted, Bhusri said.

For his part, Epstein believes “we certainly need to continue to study these findings. As technology continues to advance, and ablation procedures become safer and more effective, ablation will most certainly become the treatment of choice.”

The papers were published in the Journal of the American Medical Association.

Source : HealthDay

Are ‘Inactive’ Ingredients in Your Drugs Really So Harmless?

Steven Reinberg wrote . . . . . . . . .

More than 90 percent of the medications that Americans take contain an inactive ingredient that could cause an allergic reaction, a new study suggests.

Lactose, peanut oil, gluten and chemical dyes are added to drugs to improve taste, prolong shelf life, improve absorption or make the drug tamper-proof, researchers explained. But they can also spell trouble for patients who are allergic to those ingredients.

“About 75 percent of most pills are taken up by inactive ingredients, only 25 percent is taken up by the drug,” said lead author Dr. C. Giovanni Traverso, a gastroenterologist at Brigham and Women’s Hospital in Boston.

On average, each pill or capsule has more than eight different inactive ingredients and sometimes as many as 38, he added. Reports of patients who have had severe allergic reactions to an inactive ingredient are not uncommon.

Traverso said that when doctors prescribe a drug, they are prescribing the active ingredient only. Inactive ingredients aren’t expected to have an effect.

Doctors and patients need to be aware of the inactive ingredients in drugs, Traverso said. The full list of ingredients is often found in the brochure that goes along with the drug and can also be found in databases of the U.S. National Library of Medicine, he said.

Doctors should always ask patients about allergies not only to medications, but to the inactive ingredients they contain, Traverso added.

Moreover, doctors need to be aware of the inactive ingredients in the medications they prescribe. “There is more to a pill than just the drug,” Traverso said.

For the study, Traverso and his colleagues looked at the inactive ingredients in more than 42,000 medications. These pills and capsules contained nearly 360,000 inactive ingredients.

Analysts found 38 inactive ingredients that can cause allergic reactions after they’ve been ingested. Moreover, nearly 93 percent of the drugs the researchers studied had at least one of these ingredients.

Traverso’s team found that about 45 percent of drugs contained lactose; 33 percent contained food dye; and slightly less that 1 percent contained peanut oil.

Often, formulations of drugs that don’t contain these ingredients are available. But some medications, including progesterone, which contains peanut oil, have few alternatives.

Inactive ingredients can cause allergic reactions like hives, difficulty breathing or gastrointestinal symptoms, Traverso said.

It is not clear how much of an ingredient triggers a reaction. The amount of the ingredient — like lactose, for example — may be too low to cause a reaction in patients, except those who are severely lactose-intolerant or people taking a number of drugs that contain lactose, the researchers said.

The findings were published online March 13 in the journal Science Translational Medicine.

“We better be more careful, especially in a time of growing allergies,” said Dr. Marc Siegel, a professor of medicine at NYU Langone Medical Center in New York City.

Siegel, who wasn’t involved with the study, noted that as lactose intolerance becomes more common, and since so many drugs contain lactose, it could turn into an even bigger problem.

Also, people who say they are allergic to a drug may really be allergic to one of the ingredients, he added.

“What you thought was an allergy to your blood pressure pill was actually an allergy to lactose,” Siegel said. “We may be saying people are allergic to things [to which] they are actually not.”

Source: HealthDay


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Common Acid Reflux Medications Linked to Increased Kidney Disease Risk

Heather Buschman wrote . . . . . . . . .

Proton pump inhibitors (PPIs), which include well-known brand names Prilosec, Nexium and Prevacid, are among the most commonly prescribed medications in the world. Approximately 10 percent of adults in the United States take these drugs for frequent heartburn, acid reflux and gastroesophageal reflux disease. Given their prevalence, researchers at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego mined the FDA Adverse Effect Reporting System (FAERS) database for unexpected consequences of PPI consumption.

In the study published by Scientific Reports, the team found that patients who took PPIs were more likely to experience kidney disease than people who took histamine-2 receptor antagonists, another form of antacid that treats the same conditions and includes the brands Pepcid and Zantac.

“Post-marketing data collected by the FDA and deposited in the FAERS database allows us to look for potential adverse effects beyond what was found in a clinical trial, which may not have lasted as long or included as much diversity as the FAERS does,” said senior author Ruben Abagyan, PhD, professor of pharmacy.

Abagyan led the study with pharmacy students Tigran Makunts and Isaac Cohen, and Linda Awdishu, PharmD, associate clinical professor and chair of the Division of Clinical Pharmacy, all at Skaggs School of Pharmacy.

The FAERS database contains more than 10 million patient records — all voluntary reports of adverse effects while taking a medication. The research team focused on patients who took PPIs and no other medications, narrowing their study population down to approximately 43,000 patients. They applied a mathematical algorithm to look for statistically significant differences in reported kidney-related complications between patients who took PPIs and the control group, approximately 8,000 patients who took histamine-2 receptor blockers, such as Zantac or Pepcid, and no other medications.

Here’s what they found: Patients who took only PPIs reported a kidney-related adverse reaction at a frequency of 5.6 percent, compared to 0.7 percent for patients who took only histamine-2 receptor antagonists.

Drilling down, the team found that, compared to the control group, patients who took only PPIs were 28.4 times more likely to report chronic kidney disease, as well as acute kidney injury (4.2 times more likely), end-stage renal disease (35.5 times more likely) and unspecified kidney impairment (8 times more likely). Patients who took PPIs were also more likely to experience electrolyte abnormalities, but this varied more by individual PPI, while the kidney-specific effects held true for all five PPIs examined.

Abagyan cautioned that this study does not reveal the absolute frequency of these kidney-related complaints for all people taking PPIs, since reporting in the FAERS is voluntary. He also says it’s possible, though unlikely, the effect could be due to unidentified confounding factors. A large, randomized, controlled clinical trial would be needed to definitively show causality between PPI usage and absolute risk of kidney disease in humans.

As the World Health Organization notes, PPIs are essential medicines for many people, helping them to control symptoms that are often painful and disruptive to daily life. But Abagyan hopes this initial data will prompt health care providers to provide the appropriate warnings, education and monitoring for patients who require PPIs, particularly if they are already at elevated risk for kidney disease and electrolyte abnormalities. Researchers made similar recommendations following a 2017 UC San Diego School of Medicine study that found evidence in mice and humans that PPIs promote chronic liver disease.

PPIs are relatively inexpensive medications, retailing for approximately $7 for a recommended two-week course of generic, over-the-counter Prilosec (omeprazole). But the frequency of use adds up — one study estimated Americans spend $11 billion on PPIs each year. There are inexpensive and readily available alternatives to PPIs. However, non-PPI-based antacids (e.g., Pepto-Bismol, Tums, histamine-2 receptor antagonists) may not be as effective.

Source: University of California San Diego


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Fighting Flu with Antiviral Drugs

Most of the United States is reporting widespread flu activity according to CDC. Flu activity is expected to continue nationally for a number of weeks.

What can you do to protect yourself and your loved ones? If you have not received a flu vaccine, it is not too late! Flu vaccines reduce the risk of flu illness and potentially serious flu complications that can result in hospitalization and death. Flu activity usually peaks between December and February, although activity can last as late as May.

If you get sick with flu, antiviral drugs can be used to treat your illness.

Antiviral drugs are prescription medicines that fight against flu viruses in your body. They are different from antibiotics, which fight against bacterial infections. Antiviral drugs can lessen fever and flu symptoms, and shorten the time you are sick by about one day. They also may reduce the risk of complications such as ear infections in children, respiratory complications requiring antibiotics in adults, and hospitalization.

For people at high risk of serious flu complications, early treatment with an antiviral drug can mean having milder illness instead of more severe illness that might require a hospital stay. For adults hospitalized with flu illness, some studies have reported that early antiviral treatment can reduce their risk of death.

Patients at high risk of developing serious flu complications include pregnant women, people 65 years and older, and children younger than 5 years but especially younger than 2 years. High risk flu patients also include people with certain underlying medical conditions including heart disease and diabetes, people with neurological or neurodevelopmental conditions, and people with weakened immune systems.

Studies show that flu antiviral drugs work best for treatment when you take them within two days of getting sick. Starting them later can still be helpful, especially if the sick person has a high-risk health condition, or is very sick from flu. Doctors can choose to prescribe antivirals to treat people with mild flu illness who are not at high risk of flu complications if the patient has experienced flu symptoms for two days or less.

There’s a new antiviral drug available this flu season.

Baloxavir marboxil (trade name Xofluza®) is a new flu antiviral drug approved by the U.S. Food and Drug Administration (FDA) on October 24, 2018. Baloxavir joins oseltamivir (available as a generic or under the trade name Tamiflu®), zanamivir (trade name Relenza®), and peramivir (trade name Rapivab®) as antiviral medications for treating flu. Baloxavir is a pill, given as a single dose by mouth.

Antiviral drugs are not a substitute for getting a flu vaccine.

Getting a flu vaccine is the first and best step you can take to prevent influenza. There are many benefits to flu vaccination. Flu vaccination can keep you from getting sick with flu, and reduce your risk of flu-associated complications including hospitalization. Flu vaccination can be life-saving in children. It can also help prevent serious medical events associated with some chronic conditions such as heart and lung disease, and diabetes. Early treatment with antiviral drugs is important for people who are very sick with flu and people who get sick with flu who are at high risk of serious complications.

Bolster your flu fighting arsenal!

Good health habits can help stop the spread of flu. Everyday preventive actions include hand washing with soap and water. If soap and water are not available, use an alcohol-based hand rub. Avoid touching your eyes, nose and mouth. Germs spread this way. Cover your nose and mouth with a tissue when you cough and sneeze. Use a disinfectant to clean surfaces and objects that may be contaminated with flu viruses. If you get sick, limit contact with others as much as possible to keep from infecting them.

Source: U.S. Department of Health & Human Services


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Study: Finasteride Can Safely Lower Prostate Cancer Risk

Finasteride, best known as the enlarged-prostate medicine Proscar, is a safe, effective way to reduce the risk of prostate cancer, according to long-term findings from the Prostate Cancer Prevention Trial (PCPT).

The trial was funded by the U.S. National Cancer Institute and enrolled nearly 19,000 men between 1993 and 1997.

Initially it found that finasteride — a hormone-blocking drug — cut the risk of prostate cancer by 25 percent. Those results were published in 2003.

The newly released long-term data show that the reduction of prostate cancer risk has continued and that fewer than 100 men in the trial died from prostate cancer in more than two decades of follow-up, according to a research team led by Dr. Ian Thompson.

The updated results also showed no statistically significant increased risk of death from prostate cancer among men taking finasteride. This removes concerns over early findings of a possible risk of more aggressive cancers among patients who take the drug.

“Finasteride is safe, inexpensive and effective as a preventive strategy for prostate cancer,” said Thompson, who is principal investigator of the PCPT for the SWOG Cancer Research Network.

The SWOG Cancer Research Network is an international cancer clinical trials group.

“Doctors should share these results with men who get regular prostate-specific antigen [PSA] tests that screen for the presence of prostate cancer,” Thompson said in a SWOG news release. “The drug will have its greatest effect in this group of men.”

Thompson is also emeritus professor at the University of Texas Health Science Center. He and his team published their findings Jan. 23 in the New England Journal of Medicine.

A cheap, reliable prostate cancer prevention drug will have a big impact on public health, Thompson and his colleagues said.

They noted that prostate cancer rates are on the rise and that nearly 165,000 American men were diagnosed with the cancer in 2018, according to the American Cancer Society.

Many cases of prostate cancer are slow-growing and not life-threatening, but are still often treated with surgery and radiation, sometimes resulting in complications such as impotence and incontinence.

“There are significant negative consequences to patients’ health and quality of life that can result from prostate cancer treatment, as well as to their finances and their peace of mind,” Thompson said.

“If we can save people from surgeries and scores of examinations and tests, and spare them from living for years with fear, we should. The best-case scenario for patients is prevention, and this trial has found an inexpensive medication that gets us there,” he concluded.

One prostate specialist unconnected to the research said the new findings come after “many years of debate” on finasteride’s role in cancer prevention.

Based on early findings from the PCPT, the U.S. Food and Drug Administration “issued a warning that chronic use of the medication may increase the risk of high-grade or aggressive prostate cancer in a small percentage of men,” said Dr. Manish Vira. He helps direct urologic research at Northwell Health’s Arthur Smith Institute for Urology in Lake Success, N.Y.

Unfortunately, that warning “effectively nullified the benefits of the medication in the eyes of many patients and their physicians,” Vira said.

These later, fuller results should turn that around, he noted.

“Physicians and patients need to be aware of these results, and at least consider again using these medications in the prevention of prostate cancer,” Vira said.

“This may be especially true among men at high risk, such as African-American men and men with a strong family history of prostate cancer,” he said.

Source: HealthDay


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